LONDON, Feb. 19, 2019 /CNW/ -- In what is believed to be the first-ever ISO certification for the Design and Development of a medical device to deliver pharmaceutical-grade cannabinoids has been achieved by Senzer, the respiratory inhaler Company said today.
Senzer said the award of ISO 13485:2016 certification, after a full evaluation of its Quality Management systems by the authorising body, SGS, was a significant milestone in its regulatory pathways being pursued for approval in the US and key EU markets.
"Achieving this ISO certification is an essential pre-requisite for us on our road to market approval, and the team at Senzer are of course very excited that our quality system has been independently validated," said Senzer's Quality Director Lester Gleeson. "We will now be working towards the next regulatory milestone, which will be to have our devices CE marked."
SGS certified that under the ISO criteria, Senzer is now approved for the 'Design & Development of medical device respiratory inhalers for the delivery of pharmaceutical cannabinoids.' This is the first such approval within the pharmaceutical cannabinoid space, and the Company said it underlined the unique nature of its offering, for which more than 300 patents have been granted globally.
Senzer has developed a technology platform based around its breath-activated inhaler, which takes a different approach from all other respiratory presentations., With the Senzer platform Cannabinoids are delivered without heat or combustion, and in a defined dose, giving users certainty that they are ingesting the correct amount and form of prescribed actives. The device delivers actives in a very small particle size, allowing the cannabinoids to easily and quickly pass from the lungs into a user's circulation. This also means the dosage can be lower than other routes, such as oral ingestion, and Company has clinical data to show that the physical uptake is comparable to injections or IVs.
Senzer has focused its pharmaceutical strategy on oncology supportive care. Its first product, Candex, is aimed at relieving nausea and vomiting linked to chemotherapy, and this is undergoing FDA approval in the US. Its second, Cannafen, is aimed at alleviating neuropathic pain, another side effect of cancer treatment. The Company intends to launch both variants in key EU markets in 2019.
"Our approach enables users to enjoy swift, certain and non-invasive delivery of prescribed actives, and we believe this will be of great benefit to our initial targeted patient groups," said Senzer CEO Alex Hearn. "Our breakthrough device has numerous applications for delivering cannabinoid formulations, and not just in the pharmaceutical sector."